Video-assisted Thoracoscopic Surgery (VATS) Has Revolutionised Management of Complicated PPE, Our Study to Determine VATS Decortication Technique is Needed, Compared to VATS Debridement in PPE, Also RAPID Score and Pleural US Parameters Can Predict Which VATS Procedure is Needed.

NCT07188714 | Not Yet Recruiting DMC

• 1 other identifier: VATs,Assiut University 1
• Study Type: interventional
• Target: 95
• Locations: 1 country
• Sites: 1

Brief Summary

Video-assisted thoracoscopic surgery (VATS) has revolutionised management of complicated parapneumonic effusion ( PPE). So our study is prospective cohort study will be conducted at Departments of Chest Diseases and Cardiothoracic Surgery, Assiut University Hospitals

• Aims: to determine the frequency of which VATS technique is needed (decortication versus debridement ) and to verify whether baseline RAPID score and pleural US parameters can predict which VATS procedure (decortication vs. debridement) in patients with complicated PPE will need, upon intra-operative exploration to compare the time to ICT removal after lung expansion and length of hospital stay in patients with PPE undergoing VATS via either debridement or decortication approach .
• Subjects: All patients with PPE presenting with suggestive symptoms,signs or radiological studies which display compatible patterns of PPE:
• Inclusion criteria:
• Age \> 18 years
• Patients diagnosed with PPE who are confirmed by (aspiration of frank pus from pleural cavity, positive culture for bacterial infection, pleural fluid with a pH ⩽7.2 (measured by blood gas analyser), low glucose level (⩽3 mmol/L or ⩽55 mg•dL-1), lactate dehydrogenase (LDH) \>200 IU/L) in a patient with clinical evidence of infection .
• Failed resolution of parapneumonic effusion.
• Exclusion criteria:
• Patients unfit for/ or declining surgical intervention.
• Iatrogenic or traumatic pyothorax.
• Haemothorax or chylothorax regardless the etiology.
• Exudative pleural effusion due to medical conditions other than pneumonia .
• Sample size was calculated using Epi-info software version 7.2.5.0. The total sample size needed to detect such an estimate with 95% confidence level and 10% margin of error will be 95 patients
• Research outcome measures:
• Primary (main):
• Number of the patients who will receive either VATS technique (and the respective percentage in relation to the total patients)
• Preoperative Adjusted RAPID score and US findings (fluid volume, echogenicity, pleural thickening, consolidation and other incidental findings).
• Assessment the radiological signs of lung expansion CXR/US scores:
• Failure: Chest X-ray scoring 0 and chest US scoring 0.
• Partially successful: Chest X-ray scoring 1 or 2 and chest US scoring 1.
• Successful: Chest X-ray scoring 3 or 4, and chest US scoring 2 or 3. B. Secondary (subsidiary):
• Time to ICT removal (days). ICT tube will be removed based on the MDT joint decision according to the patients' individual course. Tube removal is contemplated upon clinical resolution, complete fluid drainage, full lung expansion and absence of pleural air in CXR, in the absence of air leak, chest ultrasound to assess if there is residual pleural effusion.
• Length of Hospital Stay (days)
• Status at discharge (ICT removed or not)
• Patients reported outcomes:
• Postoperative pain (VAS) at discharge time
• Resumption of usual activities (self-care routine with assistance - unassisted self-care- other activities indoors- independent indoors and outdoors activities) by attending the patient to the hospital within 30 days post discharge.
• Mortality rate within 30 days postoperative.

Conditions

Parapneumonic Effussion

Keywords

VATs in Parapneumonic effussion

Outcome Measures

Primary Outcomes (2)

• Assessment the radiological signs of lung expansion

  CXR/US scores: * Failure: Chest X-ray scoring 0 and chest US scoring 0. * Partially successful: Chest X-ray scoring 1 or 2 and chest US scoring 1. * Successful: Chest X-ray scoring 3 or 4, and chest US scoring 2 or 3.

  perioperative

• Preoperative Adjusted RAPID score and US findings

  Preoperative Adjusted RAPID score which determine what is the technique will be used ( decortication or debridement ) as shown : Adjusted RAPID score is a simple and easily calculated score that assesses mortality risk for patients with pleural infections. The score entails 8 parameters (Renal (urea), age, fluid purulence, infection source, dietary (albumin), diabetes mellitus, renal insufficiency (dialysis), immunosuppression are assigned as seen in Figure(1). The total adjusted RAPID score (0-10 points) represents the sum of the points assigned to the 8 parameters together, on the basis of which the patient's risk for 90 days mortality is determined . Risk categories : score 0-2 low risk score 3-4 intermediate risk score 5-7 high risk score 8-10 very high risk

  the baseline

Secondary Outcomes (1)

• Time to ICT removal (days)

  through study completion, an average of 30 days

Study Arms (2)

decortication arm

ACTIVE COMPARATOR

patients with PPE complicated by stage 3 empyema will underwent decortication technique

Procedure: VATs decortication

debridement arm

ACTIVE COMPARATOR

patients with PPE complicated by stage 2 empyema will underwent debridment technique

Procedure: VATs debridement

Interventions

VATs decortication PROCEDURE

A long thoracoscopic instruments are to be used for dissection, evacuation of pus and removal of the visceral peel at the surface of the lung. Instruments will be introduced below the lens in cases of uniportal procedure. Two ports VATS will be used early in this series by adding another 3-4 cm incision in the 3rd or 4th intercostal space anterior axillary line, scope will be introduced through the lower port and instruments will be introduced through the other. Irrigation with warm saline is to be done; breaking up the fine adhesions, the surgeon will take off the thick visceral peel over the lung surface, opening the fissures using combination of blunt and sharp dissection leaving the parietal pleura.

decortication arm

VATs debridement PROCEDURE

Removal of pus, debris, granulation tissue is to remove as much as possible of the empyema biofilm while freeing the lung from any loculations. Following debridement and flushing the pleural cavity by warm saline, the attending anaesthiologist is to modify the ventilatory settings to attain the maximally allowed degree of lung expansion (TV criteria/peak/plateau/PV curve). Then, instillation of saline to obliterate the pleural cavity until saline leaks back from the operating port. If leakage starts after instillation of ≤200 cc. (obliteration of the whole pleural cavity including the cost phrenic angle will be assumed, lung is to be considered sufficiently expanded, and VATS will be withheld at debridement step. On the other hand, if leakage starts after instillation of ≥ 200 cc, lung entrapment and failure of expansion will be assumed, and surgery will proceed to VATS decortication to achieve reasonable lung expansion

debridement arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 18 years
• Patients diagnosed with PPE who are confirmed by (aspiration of frank pus from pleural cavity, positive culture for bacterial infection, pleural fluid with a pH ⩽7.2 (measured by blood gas analyser), low glucose level (⩽3 mmol/L or ⩽55 mg•dL-1), lactate dehydrogenase (LDH) \>200 IU/L) in a patient with clinical evidence of infection \[6\].
• Failed resolution of parapneumonic effusion:
• Given a patient-to-patient variability in response to medical treatment, therapeutic pleurocentesis and ICT drainage, a MDT involving consultant cardiothoracic surgeons and consultant pulmonologist are to discuss enrolled cases individually , reach consensus, and declare failure of medical treatment or ICT drainage and need for surgical intervention , based on combination of clinical , laboratory, and radiological parameters (persistence of fever. Elevated Wbcs, respiratory symptoms, pleural fluid loculi inaccessible by ICT, lung entrapment despite complete drainage of fluid or large bronchopleural fistula

You may not qualify if:

• Patients unfit for/ or declining surgical intervention.
• Iatrogenic or traumatic pyothorax.
• Haemothorax or chylothorax regardless the aetiology.
• Exudative pleural effusion due to medical conditions other than pneumonia (suspected or proven Para malignant effusion, associated pulmonary embolism, autoimmune, pancreatic or oesophageal disease, gynaecological disorder, and drug-induced pleural effusion).

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut university- Faculty of medicine

Asyut, Assiut Governate, 71111, Egypt

Location

Related Publications (4)

• Bernstein WK, Deshpande S. Preoperative evaluation for thoracic surgery. Semin Cardiothorac Vasc Anesth. 2008 Jun;12(2):109-21. doi: 10.1177/1089253208319868.

  PMID: 18635562 BACKGROUND

• Chambers A, Routledge T, Dunning J, Scarci M. Is video-assisted thoracoscopic surgical decortication superior to open surgery in the management of adults with primary empyema? Interact Cardiovasc Thorac Surg. 2010 Aug;11(2):171-7. doi: 10.1510/icvts.2010.240408. Epub 2010 May 3.

  PMID: 20439299 BACKGROUND

• Towe CW, Carr SR, Donahue JM, Burrows WM, Perry Y, Kim S, Kosinski A, Linden PA. Morbidity and 30-day mortality after decortication for parapneumonic empyema and pleural effusion among patients in the Society of Thoracic Surgeons' General Thoracic Surgery Database. J Thorac Cardiovasc Surg. 2019 Mar;157(3):1288-1297.e4. doi: 10.1016/j.jtcvs.2018.10.157. Epub 2018 Nov 28.

  PMID: 33198004 BACKGROUND

• Dean NC, Griffith PP, Sorensen JS, McCauley L, Jones BE, Lee YC. Pleural Effusions at First ED Encounter Predict Worse Clinical Outcomes in Patients With Pneumonia. Chest. 2016 Jun;149(6):1509-15. doi: 10.1016/j.chest.2015.12.027. Epub 2016 Jan 16.

  PMID: 26836918 BACKGROUND

Related Links

• Related Info

Study Officials

• Sara Mohamed Hashem, MD

  Assiut Medical School

  STUDY CHAIR

• Hend Mohamed Sayed, MD

  Assiut Medical School

  STUDY CHAIR

Central Study Contacts

Olfat Mostafa El Shinawy, MD

CONTACT

020 01211194877; dr_olfat_mostafa@aun.edu.eg

Hussein khairy abd elaziz, MD

CONTACT

020 01005549653; Elkhayat@aun.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant lecturer

Model Details: Patients with complicated pleural infections, who don't improve after antibiotics and drainage of fluid by chest tube, will undergo surgery. The procedure may be debridement, where the surgeon only removes pus and debris, wash the thoracic cavity with saline and inserts chest tube. If the surgeon finds it necessary, he will proceed to decortication, where he also peels-off the thick infected pleura covering the lung to allow lung regain its size and help improvement. Follow up will include, clinical assessment, laboratory tests, periodic CXR to decide whether it's appropriate to remove the chest tube or not

Study Record Dates

• First Submitted: September 3, 2025
• First Posted: September 23, 2025
• Study Start: October 25, 2025
• Primary Completion (Estimated): September 10, 2027
• Study Completion (Estimated): February 10, 2028
• Last Updated: September 23, 2025

Record last verified: 2025-09

Locations

EG (1)